Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using Polyetheretherketone (PEEK) Trapezoidal Plates Versus Titanium Trapezoidal Plates

NCT ID: NCT06940115

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-06-01

Brief Summary

Some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. Very few clinical studies have been published on using a PEEK plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3D printed PEEK plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.

Detailed Description

Mandibular subcondylar fractures are common injuries that require treatment to restore function and aesthetic. Titanium plates have long been the gold standard for fixation in these fractures due to their strength, durability, and ability to provide rigid stabilization. However, they are associated with limitations such as a higher elastic modulus than bone, imaging artifacts (e.g., CT or MRI interference), and hardware-related complications. These drawbacks have prompted interest in alternative materials like polyetheretherketone (PEEK).

PEEK is a novel biomaterial with promising properties, including biocompatibility, a modulus of elasticity closer to bone, and reduced imaging artifacts. These characteristics suggest it may mitigate some of the challenges associated with titanium plates. The improved elasticity of PEEK could reduce stress shielding and enhance functional recovery, while its imaging compatibility could simplify postoperative assessments.

Researchers have shown significant interest in the application of PEEK composites in trauma plating systems, total replacement implants, and tissue scaffolds, highlighting its potential as a versatile biomaterial. Despite these advantages, evidence specifically evaluating PEEK trapezoidal plates for subcondylar fractures remains scarce, there are a no clinical studies directly comparing the outcomes of PEEK and titanium trapezoidal plates in terms of clinical outcomes. Conducting a study to evaluate these two materials would provide valuable evidence to guide material selection in mandibular subcondylar fracture management.

Conditions

Condylar Neck Fractures; Polyetheretherketone; Mandible Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

control group

CAD/CAM titanium trapezoidal plates

Group Type: EXPERIMENTAL

titanium trapezoidal plates

Intervention Type: OTHER

ORIF subcondylar fracture using trapezoidal titanium plates

comparator group

CAD/CAM polyetheretherketone (PEEK) trapezoidal plates

Group Type: EXPERIMENTAL

PEEK trapezoidal plates

Intervention Type: OTHER

ORIF subcondylar fracture using trapezoidal PEEK plates

Interventions

titanium trapezoidal plates

ORIF subcondylar fracture using trapezoidal titanium plates

Intervention Type: OTHER

PEEK trapezoidal plates

ORIF subcondylar fracture using trapezoidal PEEK plates

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older, irrespective of gender
• Recent mandibular subcondylar fractures indicated for open reduction and internal fixation

Exclusion Criteria

• Medically compromised patients contradicting operation (ASA III, IV & V).
• Patients receiving radiotherapy or chemotherapy.
• Infection at the fracture line.
• Pathological fractures and old fractures
• comminuted fractures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Yousef Badrasawi

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PEEK plate in condyle fracture

Identifier Type: -

Identifier Source: org_study_id